Inspections, Compliance, Enforcement, and Criminal Investigations
1999 Warning Letters
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Warning Letters for 1999
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* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.
* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.
Read more about warning and close-out letters
Posted on May 26, 2009
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| November 12, 1999 | Pier 7 Inc. | New England District Office | Seafood Processing Regulations/HACCP | N/A * |
| November 12, 1999 | Apheresis Technologies Inc. | Florida District Office | Quality System Regulation/Tubing Sets Plasma Filters and Blood Pumps | N/A * |
| November 12, 1999 | Bio-Laser Response Corp. | Center for Devices and Radiological Health | Laser Therapy Device/Lacks Premarket Approval/Misbranding/Mislabeling | N/A * |
| November 12, 1999 | Dr. Stjernholm Alvin & Stroupe William J. | Center for Devices and Radiological Health | Laser Therapy Devices | N/A * |
| November 10, 1999 | Viva America Corporation | Los Angeles District Office | Labeling False & Misleading | N/A * |
| November 10, 1999 | University of South Florida Health Science Center Institutional Review Boards 01 and 01B | Center for Devices and Radiological Health | IRB (Institutional Review Board) | N/A * |
| November 10, 1999 | Bio-Science Research Institute Inc. | Los Angeles District Office | Finished Pharmaceuticals | N/A * |
| November 10, 1999 | U.S. Food Service | Philadelphia District Office | Seafood Processing Regulations/HACCP | N/A * |
| November 10, 1999 | Edgewood Farms | Buffalo District Office | Cattle / Food | N/A * |
| November 10, 1999 | Star Milling Company | Los Angeles District Office | Medicated Feeds/CGMP | N/A * |
| November 10, 1999 | Southern Connecticut State University Institutional Review Board | Center for Devices and Radiological Health | IRB (Institutional Review Board) | N/A * |
| November 10, 1999 | B & B Fisheries Inc. | Florida District Office | Seafood Processing Regulations/HACCP | N/A * |
| November 09, 1999 | Sierra Cattle Company | San Francisco District Office | Dairy and Feeder Cattle Operations | N/A * |
| November 09, 1999 | Mike's Quality Meats | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
| November 09, 1999 | Fourchon Seafood Inc. | New Orleans District Office | Seafood Processing Regulations/HACCP | N/A * |
| November 09, 1999 | Captain Henry Seafood Inc. | New Orleans District Office | Seafood Processing Regulations/HACCP | N/A * |
| November 09, 1999 | Crystal Mountain Inc. | Nashville District Office | Food Labeling | N/A * |
| November 08, 1999 | IDEC Pharmaceutical Corporation | Center for Biologics Evaluation and Research | CGMP/Pharmaceutical Manufacturing Facility | N/A * |
| November 08, 1999 | Zumbrota Health Care | Minneapolis District Office | Mammography Standards | N/A * |
| November 05, 1999 | Virginia Blood Services Inc. | Baltimore District Office | Blood Products / Standard Operating Procedures | N/A * |
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